J
Freas, William
From: Sent: To: Subject: Terry S. Singeltary Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas@CBS5055530.CBER.FDA.GOV CJDIBSE (aka madcow) Human/Animal TSE’s--U.S.--Submission Consultants Staff January 2001 Meeting (short version)
To Scientific Advisors and
Greetings
again
Dr.
Freas
and Committee
Members, to the
I wish to submit the following information Scientific Advisors and Consultants Staff 2001 Advisory Committee (short version).
I understand the reason of having to shorten my submission, but only hope that you add it to a copy of the long version, for members to take and read at their pleasure, (if cost is problem, bill me, address below). So when they realize some time in the near future of the 'real' risks i speak of from human/animal TSEs and blood/surgical products. I cannot explain the 'real' risk of this in 5 or 10 minutes at some meeting, or on 2 or 3 pages, but will attempt here: remember AIDS/HIV, no need to go into 'no problem to heterosexuals in the U.S.? that, you know of this blunder:
,.
DO NOT make these same stupid mistakes again with human/animal TSE's aka MADCOW DISEASE. I lost my Mom to hvCJD, and my neighbor lost his Mother to sC3D as well (both cases confirmed). I have seen many deaths, from many diseases. I have never seen anything as CJD, I still see my Mom laying helpless, jerking tremendously, and screaming "God, what's wrong I stop this". I still see this, and will with me, why can't never forget. Approximately 10 weeks from 1st of symptoms to death. This is what drives me. I have learned more in 3 years about not only human/animal TSE's but the cattle/rendering/feeding industry/government than i ever wished to. I think you are all aware of CJD vs vCJD, but i don't think you all know the facts of human/animal TSE's as a whole, they are all very very similar, and are all tied to the GREED and MAN. same thing, I am beginning to think that the endless attempt to track down and ban, potentia.1 victims from known BSE Countries from giving blood will be futile. You would have to ban everyone on the Globe eventually? AS well, I think we MUST ACT SWIFTLY to find blood test for TSE's, whether it be blood test, urine test, .eyelid test, anything at whatever cost, we need a test FAST.
DO
, you.
NOT let
the
incubation
time
period
of these
TSEs fool
To think of Scrapie as the prime agent to compare CJD, but yet overlook the Louping-ill vaccine event in 1930's of which 1000's of sheep where infected by scrapie from a vaccine made of scrapie infected sheep brains, would be foolish. I acquired this full text version of the event which was recorded in the Annual Congress of 1946 ational Vet. Med. Ass. of Great Britain and Ireland. " I rom the BVA and the URL is posted in my (long version). U.S.A. should make all human/animal TSE's notifiable at all with requirements for a thorough surveillance and post-mortem
I
ages,
.
examinations this horrible
if you are serious free of charge, disease in man and animal.
about
eradicating
o florid plaques" There is histopathology reports describing in CJD victims in the USA and some of these victims are getting younger. I have copies of such autopsies, there has to human TSE's will most definitely be more. PLUS, sub-clinical be a problem. THEN used this PNAS think of vaccineCJD in children and the bovine tissues in the manufacturing process, think of the FACT that agent surviving 6OO*C. -- Brown et al. 97 (7): 3418 scrapie agent live at 600*C
Then think of the CONFIDENTIAL documents of what was known of human/animal TSE and vaccines in the mid to late 8Os, it was all about to hell with the kids, BUT yet they knew. depletion of stock, To think of the recall and worry of TSE's from the polio vaccine, (one taken orally i think?), but yet neglect to act on the other potential TSE vaccines (inoculations, the most effective mode to transmit TSEs) of which thousands of doses were kept and used, again would be foolish. to deplete stockpile, polio; up to 1988, foetal calf serum was used from UK and since 1988 foetal calf serum only from New New Zealand (pooled); Zealand. Large stocks are held. --Rubella; bulk and New Zealand. was made before 1979 from foetal calf serum from UK None has been made as there are some 15 years stock. since litres Scottish. litres the of --Oral
..
--Diphtheria; UK bovine beef muscle and ox heart is used but end of 1988 this has been sourced from Eire. There are 1,250 stock. --Tetanus; this involves There are 21,000 litres --Pertussis; of stock. uses bovine bovine material of stock. material from the UK mainly UK. There
from the
are 63,000
--They consider that to switch to a non-UK source will 6-18 months and to switch to a non-bovine source will five years. 3. XXXXXXXXXXX have measles, mumps, MMR, rubella are sourced from the USA and the company believes is used. 89/2.14/2.1 ============ BSE3/1 0251
take a minimum of take a minimum of
vaccines. These that US material
only
4. XXXXXXXXXXX have a measles vaccine using bovine serum from the UK. there are 440,000 units of stock. They have also got MMR using bovine serum from the UK.
5. XXXXXXXXXXX have influenza, likely to be used in children. contains bovine material which
rubella, measles,' MMR vaccines Of those they think that only is probably a French origin.
MMR
6. XXXXXXXXXXX have diphtheria/tetanus hese use veal material, some of which ade by XXXXXXXXXXX (see above).
and potasses on clinical trial. has come from the UK and has been
I have documents of imports from known BSE Countries, of ferments, whole blood, antiallergenic preparations,
2
human blood plasma, normal human blood sera, human immune bovine serum, and other blood fractions blood sera, fetal not elsewhere specified or included, imported glands, vaccines for both human/animal, as late as 1998. catgut, Let us not forget about PITUITARY EXTRACT. This was used to help This tissue was considered to be of greatest risk super ovulate. containing BSE and consequently transmitting the disease. ANNEX 6
COWS
of
MEETING HELD ON 8 JUNE 1988 TO DISCUSS THE IMPLICATIONS OF BSE TO BIOLOGICAL PRODUCTSCONTAINING BOVINE - EXTRACTED MATERIAL How much of this was used in the U.S.?
Please do not keep making the same mistakes; 'Absence of evidence is not evidence of absence'. for importing What are the U.S. rules medicines and medical devices?
Does
and manufacturing
vaccines, from ..
the
the U.S.A. U.S.A.?
allow
sourcing
of raw material can you give amplify
of ruminants for
U.S. cattle, tissue donor The U.S.
what kind herds.?
of guarantee would
serum or
rendering
system
easily
T.S.E.'s: heat treatments)
Have we increased the stability of the system (improved since the EU SSC report on the U.S.A. was published in july 2000? What is done to avoid cross-contaminations in the U.S.A.?
How can the U.S. control absence of cross-contaminations of animal TSE's when pig and horse MBM and even deer and elk are allowed in ruminant feed, as well as bovine blood? I sadly think of the rendering and feeding policy before the Aug. 4, 1997 'partial' feed ban, where anything went, from the city police horse, to the circus elephant, i will not mention all the scrapie infected sheep. I am surprised that we have not included man 'aka soyent green'. It is a disgusting industry and nothing more than greed fuels it. When will population When will the U.S.. start (not passive, U.S. start real this surveillance of the U.S. bovine will not work)? SRMs?
removing
Have they stopped the use of pneumatic stunners in the U.S.? If so, will we stop it in all U.S. abattoirs or only in those abattoirs exporting to Europe? If not, WHY NOT? same questions for or just for export? If not, WHY NOT? removal of SRM in the U.S.A.,
How do we now sterilize
surgical/dental
instruments floor
in the U.S.A.? you)
Where have we been sourcing surgical catgut? (i have copies of imports to U.S., and it would hen will re-usable surgical instruments
be banned? containing from various
supplements' 'Unregulated "foods" such as 'nutritional extracts from ruminants, whether imported or derived
3
US cattle/sheep/cervids ("antler velvet" extracts!) should be forbidden or at least very seriously regulated. died from CJD, had been taking (neighbors Mom, whom also which contained brain, eye, and many bovine based supplement, 'IPLEX'). other bovine/ovine tissues for years, What is the use of banning blood or tissue donors exposing cattle, when the U.S.A. continues etc... SRM, refuses to have a serious feed ban, refuses to do systematic BSE-surveillance? from Germany, France, sheep and people to
The FDA should feel responsible for the safety of what people eat, prohibit the most dangerous foods, not only prohibit a few more donors the FDA should be responsible for the safe sourcing of medical devices, not only rely on banning donors "from Europe",_ . . risks are here in the U.S. as well, and nave been for some The 'real' time. We must not infectivity The Lancet, forget the studies that in blood from TSE's. November 9, 1985 have proven
-
Manuelidis and his colleagues (Ott 19, p896) report Sir, --Professor transmission to animals of Creutzfeldt-Jakob disease (CJD) from the We also transmitted the disease from buffy coat from two patients. whole blood samples of a patient (and of mice) infected with CJD.l from this patient were also infectious, Brain, Cornea, and urine and the clinicopathological findings2 are summarised as follows. snip... Samples,were taken aseptically at necropsy. 10% crude homogenates whole blood (after crushing a clot), of brain and cornea in saline, and untreated CSF a,nd urine were innoculated infracerebrally into 'CFl strain mice (20 ul per animal). Some mice showed emaciation, rigidity of the body and tail, and sometimes tremor bradykinesia, Tissues obtained after the animal after long incubation periods. died (or was killed) were studied histologically (table). Animals infected by various inocula shpwed,,co,n?mon pathological changes, consisting of severe spongiform changes, glial proliferation, and A few mice inoculated with brain a moderate loss of nerve c,ells. tissue or urine had the same,amyldid.pl&'Gue's fou"nd in'patients and animals with CJD.3 snip... Department of Neuropathology,. Neurological Institute, Faculty of Medicine, Kyushu University, Fukuoka812, Japan JUN TATEISHI (full and CWD and transmission to man will be no different than other TSE's. text-long version)
" ,
it is premature to draw firm conclusions about CWD "Clearly, assing naturally into humans, cattle and sheep, but the present esults suggest that CWD transmissions to humans would be as limited by PrP incompatibility as transmissions of BSE or there is no evidence that sheep sheep scrapie to humans. Although that BSE has scrapie has affected humans, it is likely 4
caused variant CJD in 74 people (definite and probable variant CJD cases to date according to the UK CJD Surveillance Unit). Given the presumably large number of people exposed to BSE infectivity, the susceptibility of be very low compared with humans may still which would be consistent with the relatively inefficient cattle, conversion of human PrP-sen by PrPBSE. Nonetheless, since humans have apparently been infected by BSE, it would seem prudent to take reasonable measures to limit exposure of humans (as well as sheep and cattle) to CWD infectivity as has been recommended for other animal TSEs," G.J. Raymondl, A. BossersZ, L.D. Raymondl, K.I. L.E. McHolland4, P.K. Bryant 1114, M.W. MillerS, Smits2 and B. Caugheyl,7 or more recently Research letters Transmission Lancet 2000; transmission Volume 356, O'Rourke3, E.S. Williams6, M.
of BSE to sheep via whole blood Number 9234 16 September 2000 transfusion in sheep
of BSE by blood 356: 999 - 1000 Angela
F Houston,
J D Foster,
Chong,
N Hunter,
C J Bostock
..
See Commentary "We have shown that it is possible to transmit bovine spongiform encephalopathy (BSE) to a sheep by transfusion with whole blood taken from another sheep during the symptom-free phase of an experimental BSE infection. BSE and variant Creutzfeldt-Jakob disease (vCJD) in human beings are caused by the same infectious model agent, and the sheep-BSE experimental has a similar pathogenesis to that of human vCJD. Although UK blood transfusions are leucodepleted--a possible protective measure against any risk from blood this report suggests that blood transmission-donated by symptom-free vCJD-infected human beings may represent a risk of spread of vCJD infection among the human population of the UK." "The demonstration that the new variantof Creutzfeldt-Jakob disease (vCJD) is caused by the same agent that causes bovine spongiform encephalopathy (BSE) in cattle1 has raised concerns that blood from human beings in the symptom-free stages of vCJD could transmit infection to recipients of blood transfusions (full text long version)" and... "The large number of cases (1040), temporal clustering of the outbreaks (15 in the first 6 months of 1997), the high in-flock and the exceptional involvement of goats (390 cases), incidence, The source of the epidemic suggested an accidental infection. might have been TSE-contaminated meat and bonemeal, but eight flocks had never been fed any commercial feedstuff. Infection might have risen from the use of a formol-inactivated vaccine against contagious agalactia prepared by a single laboratory with brain and mammary gland homogenates of sheep infected with Mycoplasma agalactiae. Although clinical signs of TSE in the donor sheep have not been found, it is possible that one or more of them were harbouring the .
I
was ?lven infectious agent. Between 1995 and 1996, this vaccm flocks (to one flock 1.n subcutaneously to 15 of the affected between 23 and 35 1994) ; in these animals the disease appeared available is for months after vaccination. No information it was made up of stolen animals.. Sheep from the herd 13 because remaining three flocks (l-3, figure) did not re;;;ce;sLhz thus suggesting a naturally occurring vaccine, full text long version). (again,
IN SHORT, please do under estimate this human/animal TSE's including CWD in the A few last words, please.
data and or U.S.A.
The cattle industry would love to have us turn our focus to CWD and forget about our own home grown TSE in Bovines. This would be easy to do. Marsh's work was from downer cattle feed, NOT downer deer/elk feed. This has been proven. DO NOT MAKE THAT MISTAKE. There should be NO LESS THAN l,OOO,OOO tests for BSE/TSE French are testing 20,000 a week. in 2001 for U.S.A. Why wait until we stumble across The tests are available. a case from passive surveillance, by then it is to late. IF we want the truth, this is a must??? United States Total thru ,Bovine Brain 31, 2000 Submissions by State, '
May lo,1990 Total
,.fl--\,
October
11,700 HEAD OF CATTLE since 1990 ???
FROM 1.5 BILLION
with same feeding and rendering practices as that of U.K. for years and years, same scrapie infected sheep used in feed, for years and years, 950 scrapie infect FLOCKS in the U.S. and over 20 different strains of scrapie known to date. (hmmm, i am thinking why there is not a variant scrapid, that is totally different than all the rest)? just being sarcastic. with only PARTIAL FEED BAN implemented on Aug. 4, 1997??? (you really need to reconsider that blood meal etc. 'TOTAL BAN') http://www.aphis.usda.gov/oa/bse/bsesurv,ey.html#charts AND PLEASE FOR GODS SAKE, STOP saying vCJD victims are the only ones tied to this environmental death sentence. "PROVE IT". It's just not true. The 'CHOSEN ONES' are not the only ones dying because of this man-made death sentence. When making regulations for human health from human/animal include ALL human TSE's, not just TSEs, you had better vCJD. Do NOT underestimate sporadic CJD with the 'prehistoric' testing available to date. This could be a deadly mistake. Remember, sCJD kills much faster from 1st onset.of symptoms to death, and hvCJD is the fastest. Could it just be a higher titre of infectivity, or route or source, or all three? Last, but not least. The illegal/legal harvesting of body parts and tissues . will come back to haunt you. Maybe not morally, . . J-..put due to NO background checks and human TSEs, again it i will continue to spread. Stupidity, Ignorance and Greed is what fuels this "->- m11st stop all of this, and ACT AT ONCE... disease.